Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
02/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HN9

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised double-blind placebo controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Head and neck

Intervention

1. Group A: Active SSD pastille (Polymyxin E 2 mg, Tobramycin 1.8 mg and Amphotericin B 10 mg). Treatment to start on the day radiotherapy begins, one pastille four times daily until radiation reactions have settled.
2. Group B: Placebo pastille four times daily. Treatment to start on the first day of radiotherapy until radiation reactions have settled.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1999

Overall trial end date

31/12/2000

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with head and neck cancer receiving potentially curative doses of radiotherapy
2. Eligible patients may have squamous carcinoma, adenocarcinoma or salivary tumours arising in the oral cavity, nas -oro, or hypopharynx, larynx and paranasal sinuses
3. Stages T1-T4
4. No allergy to Polymyxin E, Tobramycin or Amphotericin B
5. No pre-existing oral or oropharyngeal infection

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1999

Recruitment end date

31/12/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

UK Co-ordinating Committee for Cancer Research (UKCCCR)

Sponsor details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Not defined

Funder name

Not available

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 1996 results in http://www.ncbi.nlm.nih.gov/pubmed/8688343

Publication citations

  1. Results

    Symonds RP, McIlroy P, Khorrami J, Paul J, Pyper E, Alcock SR, McCallum I, Speekenbrink AB, McMurray A, Lindemann E, Thomas M, The reduction of radiation mucositis by selective decontamination antibiotic pastilles: a placebo-controlled double-blind trial., Br. J. Cancer, 1996, 74, 2, 312-317.

Additional files

Editorial Notes